RELATED APPLICATION DATA

This application is a continuation-in-part of U.S. Ser. No. 07/659,603, filed Feb. 21, 1991, now U.S. Pat. No. 5,097,848, issued Mar. 24, 1992 which is a divisional of U.S. Ser. No. 07/580,198, filed Sep. 10, 1990, now U.S. Pat. No. 5,012,822, issued May 7, 1991, which is a divisional of U.S. Ser. No. 07/256,650, filed Oct. 11, 1988, now U.S. Pat. No. 4,969,474, issued Nov. 13, 1990.

BACKGROUND OF THE INVENTION

The present invention pertains generally to the treatment of urinary incontinence and more particularly to an incontinent bladder control method and apparatus incorporating a prosthesis for selectively restricting urine flow in a urethra.

Both males and females have an external sphincter formed about the urethra which, when functioning normally, constricts the urethra and prevents flow of urine from the bladder except when the bladder is voided during normal urination.

Urinary incontinence may result from several causes. For example, in females stretching or lengthening of the pelvic attachments to the bladder and urethra (termed cystocele and urethrocele) may occur, such as following a normal vaginal parturition, thereby allowing the bladder to descend from a normal position (FIG. 1) into a lower position (FIG. 2) thus functionally shortening the urethra. This form of incontinence may be surgically corrected by re-securing the bladder and urethra into a normal or near-normal position in the pelvis (FIG. 3), thereby regaining normal or additional urethral length. In this type of incontinence, the essential elements of the sphincter are intact.

A more difficult form of urinary incontinence relates to iatrogenic injury to the urethral sphincter. Such injury is common in the male following certain types of prostate surgery (e.g., for prostate malignancy and sometimes for benign prostatic hypertrophy) and produces incontinence as result of damage to or loss of the external urethral sphincter. This form of incontinence is treated by repair or augmentation of the sphincter, or by substitution of its function by implantation of a prosthetic sphincter. It is not treatable by repositioning surgery, as in the case of female urethrocele/cystocele, because that surgery requires an intact sphincter.

There are numerous prior art prosthetic sphincters for selectively closing and opening the urethra to prevent incontinence. These devices typically incorporate an inflatable cuff which surrounds the urethra or encloses it on two sides, and which is inflated to restrict urine flow in the urethra. Examples of such prosthetic sphincters are seen in U.S. Pat. No. 4,571,749 to Fischell, U.S. Pat. No. 4,222,377 to Burton and in other prior patents referenced in applicant's prior patents.

Implementing this approach can encounter surgical difficulties and using it involves problems of control, both with potentially serious complications. Surgery in the female requires a difficult dissection behind the bladder neck and urethra, risking perforation of the adjacent vaginal wall. In males, dissection in this area encounters the prostate and rectum, risking rectal injury/fistula.

After implantation, control and maintenance of pressure in the cuff has been found to be difficult. Inadequate pressure (inflation) applied by such prior art devices may fail to occlude the urethra and thus permit continued incontinence. When sufficient pressure is applied, incontinence can be initially prevented but then may recur as result of partial tissue loss or necrosis of the urethra due to excessive localized pressure applied to the urethra by the prosthetic sphincter.

U.S. Pat. No. 4,846,784 to Haber discloses a manually adjustable sphincteric system, which is inserted as a unit periurethrally in the male via a trocar. In operation, inflation of a balloon located adjacent the bulbar urethra increases local tissue density in the area of the proximal corpus spongiosum. This approach is limited to use in the male.

Another drawback associated with the prior art prosthetic sphincters, which are activated by transfer of an incompressible fluid, relates to the complex control systems used for inflating and deflating the sphincter. Examples of such prior art systems are seen in U.S. Pat. No. 4,571,749 to Fischell and in U.S. Pat. No. 3,744,063, which includes a fluidic control system for inflating and deflating an artificial sphincter that includes four check valves. U.S. Pat. No. 4,846,784 to Haber uses a simpler form of releasable check valve, but discloses no way to control intra-system fluid pressures without further surgery. Other examples are cited in applicant's prior patents.

The disadvantages of implantable prosthetic devices can, in many instances, outweight their advantages. Infections associated with implanted foreign materials require removal with resultant scar tissue which usually precludes repeat surgery (implantation) at that site. Infections most commonly occur when other problems concerning complex prosthetic devices require secondary surgery. Examples of this situation include replacement of defective component parts, leakage of fluid from hydrologically actuated devices, and tissue erosion associated with inflatable prosthetics. The currently available artificial urinary sphincter demonstrates all of the above disadvantages. These have lead to a failure rate ranging from 5-10% and infection rate of about 5%.

These problems prompted development of a simplified prosthesis and method of controlling incontinence as disclosed in applicant's U.S. Pat. No. 4,969,474 and U.S. Pat. No. 5,012,822. These are effective to minimize the above complications and to improve treatment of severe urinary incontinence. The device incorporates fluid transfer between multiple (2) components of a self-contained fully implantable device. As originally conceived, the device is intended to be surgically implanted as a unit with percutaneous access for patients who can manually operate the voiding feature of the device. A fully implantable device avoids external contamination following surgery. The main disadvantage of this approach, as in other systems, is the need for major surgery to perform the implantation. A further disadvantage is the need for secondary surgery for failure of any component or tissue change (erosion) which in prior and current designs can produce loss of function (recurrent incontinence). Repeated or extensive surgery is associated with excessive scar formation which, in turn, reduces blood supply to the area of the prosthesis. High infection rates are directly related to diminished blood supply.

A need, therefore, remains for a way to implant a urinary incontinence device which reduces the extent of surgery and the likelihood of subsequent surgical revisions.

SUMMARY OF INVENTION

It is an object of the present invention to provide a method and apparatus for treatment of incontinent bladder function which overcomes the disadvantages of prior art devices and methods.

A further object of the invention is to provide a prosthesis which is simply constructed and which may be easily used by a patient to selectively restrict or permit urine flow in the urethra.

Another object is to provide such a urinary incontinence treatment method and apparatus capable of restricting urine flow without compressing the urethra to the extent that tissue loss or necrosis occurs.

Yet another object of the invention as aforesaid is to enable treatment of incontinence in both males and females in the same way and with similar effectiveness.

An additional object is to provide a method of implantation, usable in either a male or female, which reduces the difficulties encountered in prior techniques with surgical trauma, infection, scarring and repeat surgery, and difficulties in control of the device in operation.

The apparatus of the invention is an artificial sphincter which comprises a reservoir containing fluid and an inflatable compression means positionable between the bone of a human pelvis and the bladder neck and superior urethra and in fluid communication with the reservoir via a conduit. A releasable one-way valve means is included in the conduit between the reservoir and compression means for controlling and maintaining inflation of the compression means. The compression means is designed to fit between the posterior symphysis of the patient's pubis and anterior side of the patient's urethra, or along one lateral side of the urethra. So positioned, inflation of the compression means compresses the urethra along one side and over an extended area to occlude the urethral lumen. The compression means preferably includes means for directing inflation preferentially in an inferior-posterior direction, i.e., parallel to the posterior symphysis pubis, to impinge upon the anterior and/or lateral aspect(s) of the urethra.

The method of controlling incontinence comprises the steps of (a) elevating the patient's bladder, (b) elongating the urethra and (c) compressing a lengthwise extent of the urethra along one side thereof. This is preferably done by surgically implanting the inflatable compression means at the neck of the elevated bladder between the pubis and ventral side of the urethra and releasably inflating the compression means. Inflation of the compression means can be directionally channelled for urging the same against the urethra along a substantial portion of its length.

Placement and operational effectiveness of the compression means are aided by elevating the bladder. This functionally lengthens the urethra and reduces lumen size so that it can be occluded more easily by inflating the compression means. Inflation of the compression means on only one side of the urethra and over an extended area of its length minimizes risk of necrosis of urethral tissue. Compression of the urethra is only against pelvic soft tissue components. Control will be at least partially responsive to intraabdominal pressure variations, e.g., due to bladder filling, coughing, so as to help maintain continence.

Another feature of the invention is a multistep implantation method in which (a) the compression means and conduit of the artificial sphincter is implanted in a first procedure using minor surgical techniques with a sheath-type insertion device, such as a laparoscope or a trocar with or without optical viewing, to introduce and position the compression means along one side of the urethra, preferably the anterior; (b) external inflation and test apparatus is connected transcutaneously via the conduit to the compression means and operated to establish proper pressures for occluding and releasing the urethra; and (c) the remainder of the incontinence control device is subsequently implanted, typically in a second procedure, and charged to a total volume to provide the requisite pressures established by testing the device in vivo. Sufficient time, e.g., two weeks, is provided between procedures to permit healing and subsidence of swelling. This method is applicable to both men and women, and avoids many of the problems of conventional surgical implantation.

A laparoscope is preferably used in placing the compression balloon. The magnification and optics of the laparoscopic instruments aid in precise placement of the compression means (balloon positioning), which is an important feature of the surgical method employed. An optical system can be incorporated into a specially-designed trocar to assist placement utilizing laparascopic techniques. Thus, it is anticipated that the use of laparoscopic instruments and techniques will improve the long term success of the prosthesis by simplifying the surgical method. Both procedures are likely to be accomplished under local anesthesia. Cost advantages would also be realized, as well as reduced patient discomfort and earlier return to normal activities. The disadvantages of this method will be the potential for infection (currently less than 1%) and the inconvenience and discomfort of an external catheter following the first procedure. These disadvantages are mitigated by the relatively brief need for external access to the conduit and the advantages of individual testing.

The most significant advantage of the new method is the definition of individual parameters, chiefly the volume required to maintain continence, prior to definitive (full) implantation. Urodynamic assessment to record pressures within and/or adjacent to the urethra will also help minimize the potential for tissue erosion. Some of these assessments can be accomplished at the time of initial placement, and several weeks thereafter when swelling associated with initial surgery has subsided. Assessment via ambulatory (continuous) monitoring could prove useful in defining safe parameters for use under varying conditions (positions, activities, etc.). An additional advantage will be the easy removal, without additional surgery, of the compression balloon catheter for replacement with an alternative design (shape or size), if the initial configuration proves inadequate or painful. Variability of anatomy (stature, configuration of pubic bones and tissue status (prior bladder and/or urethral surgery), makes this approach very practical. Thus, modifications can be made in the test phase of the surgical implantation that will minimize the need for later revisions and risk of late infection.

The second procedure is implantation and connection of a reservoir valve assembly to the conduit and will follow the first procedure after a short interval. This is not likely to be more than several days but could extend from two weeks to a month or more if needed to allow for changes related to healing to occur between procedures.

Further objects, features and advantages obtained by the instant invention will become more fully apparent when the following detailed description of a preferred embodiment is read in view of the accompanying drawings.

DETAILED DESCRIPTION

Turning now to the drawings, and more particularly to FIG. 1, indicated generally at 10 is a simplified diagram of a portion of normal anatomy of a female in standing position. Included in this lateral view is a bladder 11, bladder neck 12 and a urethra 14. Also included is the pubis bone 16. The distal end 13 of the urethra is a relatively fixed position by virtue of attachments 17 to the inferior pubic arch and anterior-superior vaginal tissues. A sphincter surrounding the urethra normally maintains the lumen or central opening through urethra 14 in a closed condition thereby preventing urine from traversing the urethra. Relaxing the sphincter opens the lumen to permit voiding of urine from bladder 11.

Turning now to FIG. 2, indicated generally at 18 is a view similar to FIG. 1 illustrating an anatomic defect which may occur in females and which is referred to as cystocele and/or urethrocele, producing "stress" incontinence. Structures corresponding to those previously illustrated and described in FIG. 1 bear the same numbers in FIG. 2.

The cystocele/urethrocele condition is defined as a downward migration of bladder 11, bladder neck 12 and urethra 14 from the normal position shown in FIG. 1 to the position shown in FIG. 2. Such migration is typically a result of a structurally inadequate muscular floor of the anterior pelvis. It is thought to be a normal aging process accelerated by pregnancy and vaginal delivery of the fetus. Stretching or lengthening of the pelvic attachments to the bladder and urethra permits bladder 11 and urethra 14 to descend into the lower position shown in FIG. 2.

When in the lowered position of FIG. 2 with its distal end 13 attached as indicated at 17, urethra 14 is effectively shortened and thus the lumen assumes a larger effective diameter. With the lumen diameter so enlarged, the sphincter itself may be distended, lack sufficient range and/or strength to fully occlude the lumen, thereby resulting in urinary stress incontinence.

Urinary incontinence of the cystocele/urethrocele type illustrated in FIG. 2 can typically be successfully corrected by various conventional surgical procedures. FIG. 3 illustrates the anatomy after successful surgical correction of the cystocele/urethrocele condition of FIG. 2. The procedure consists of elevating the bladder and fixing it by sutures 15 to the posterior surface of the superior pubic arch. This functionally lengthens the posterior surface of the urethra 14 by bringing bladder neck 12 and urethra back into a more superior and anterior position from the location shown in FIG. 2 while the attachments 17 retain the distal end 13 in place below the pubis 16.

A more difficult form of urinary incontinence relates to iatrogenic injury which is common in the male following surgery for prostate malignancy, and, in some instances, surgery for benign prostatic hypertrophy. This form of incontinence is secondary to damage to or loss of the muscle and/or nerve elements of the external sphincter mechanism. Prosthetic surgery has been necessary to correct this type of defect since normal muscle and/or nerve supply is irreparably lost; thus, a substitute sphincter must be utilized. As discussed above, the prior art methods using artificial sphincters have various drawbacks that my invention avoids as next described.

Turning now to FIG. 4, indicated generally at 20 is a prosthetic device constructed in accordance with the invention implanted in a female. Anatomy corresponding to that previously identified in FIGS. 1-3 is identified with the same numbers in FIG. 4.

Generally speaking, device 20 includes a compressible reservoir balloon 22, an inflatable balloon 24, which functions as an inflatable compression means, and a tube 26 providing fluid communication between balloons 22, 24. A lateral attachment tab 28 fixed to the superior pubis 16 secures tube 26 and thus balloons 22, 24 in position as shown. A quantity of a suitable liquid is contained within tube 26 and balloons 22, 24. As more fully explained, a transfer of liquid into balloon 24 is used to selectively compress urethra 14 in an anterior-posterior direction in an area just above the location of the natural sphincter. The compression platform against which the urethra is compressed is ultimately the sacrum and coccyx with intervening rectum and pelvic viscera providing a buffer (see FIGS. 8-10). The total volume of fluid in the device 20 is controlled by adding fluid to or subtracting fluid from the device by inserting a noncoring needle through a self-sealing diaphragm 23 in the anterior wall of reservoir 22.

An important part of the surgical procedure of implanting device 20 includes fixing the anterior-superior bladder to the posterior rectus fascia above the level of the superior pubic rami. This is accomplished by sewing a 1 cm. by 2-3 cm. felt matrix or mesh patch 30 to the anterior bladder wall. The patch in turn is then sewn to the posterior aspect of the rectus fascia (not shown) via suture 32. Additional detail concerning the implantation of device 20 and the anchoring of the bladder via suture 32 is provided hereinafter. Attention is now directed to FIGS. 5, 5A, 5B, 5C, 6 and 7 for more detailed consideration of the structure of device 20.

Device 20, except for attachment tab 28 and a pair of staples 34, 36 which are used to anchor the lateral attachment tabs 29 of attachment 28 as shown in FIG. 4, is constructed of or encased by conventional plastic implantable material.

Reservoir balloon 22 is shaped to contain a relatively large volume of fluid while maintaining a relatively small anterior-posterior width as viewed in FIG. 4. The relatively wide lateral dimension of balloon 22, as viewed in FIG. 5A, overlies the broad expanse of anterior pubic bone 16 when implanted.

Compression balloon 24 similarly has a somewhat flattened shape with an oval cross section best seen in FIGS. 5B and 5C. This shape helps locate and maintain the compression balloon in position between the concavity of the pubic symphysis and the anterior urethra.

In the first embodiment shown in FIG. 6, balloon 24 includes a restraining means or skirt-like cup 38 fixedly attached to tubing 26 as shown in FIG. 5B. As fluid moves from balloon 22 to balloon 24 via tube 26, in a manner which is hereinafter more fully described, cup 38 restricts expansion of balloon 24 to a direction substantially downwardly along an axis 40 in FIG. 5B. The dashed line outline 24' in FIG. 5B illustrates the configuration of the lower portion of balloon 24 when the same is further inflated from the solid-line view of FIG. 5B. The dashed line configuration is obtained because of the restraining action of cup 38 on the expansion of upper portion of balloon 24.

FIGS. 6 and 7 are more detailed sectional views of device 20 and an alternate embodiment 44 respectively, constructed in accordance with the invention. Both embodiments of the invention as disclosed in FIG. 6 and FIG. 7 incorporate the same structure in balloon 22 up to and including the attachment of the same to tube 26. Thus, in the views of FIGS. 6 and 7 all structure to the left of the break-line in tube 26 is substantially identical in each embodiment and thus contain the same reference numerals in the various figures.

Referring to FIG. 6, a check valve 46 is incorporated into balloon 22 at the entrance to tube 26. In the example shown, valve 46 includes a resilient cylindrical valve body 48 having an axial bore 50. One end of bore 50 communicates with balloon 22 along a substantially planar side 52 of valve body 48 while the other end of bore 50 communicates with tube 26 along an opposite convex or dome-shaped side 54 of the valve body. A resilient circular membrane 56 is attached about the circumference of side 54 to the inside of the wall of balloon 22 and, in the view of FIG. 6, is flushly sealed against side 54. Membrane 56 has pair of openings 57, 59 spaced radially apart from the center of the membrane and from axial bore 50. In the closed position shown in FIG. 6, a greater pressure on the right side of membrane 56 seals the membrane against dome 54 to block openings 57, 59 and prevent fluid flow from tube 26 to bore 50.

The embodiment of FIG. 7 illustrates check valve 46 in its open condition. Compression of valve body 48 via a patient's thumb 72 and forefinger 74 deforms the valve body 48 and lifts membrane 56. This action opens holes 57, 59, allowing fluid to flow via bore 50 into reservoir 22. Additional details concerning the opening of check valve 46 are provided hereinafter in connection with the description of operation of the various embodiments of the invention.

At its juncture with tube 26, balloon 22 forms a resilient connecting member 58. Member 58, as seen in FIGS. 6 and 7, includes thickened walls which resiliently maintains member 58 in a domed shaped spaced axially from the valve body as shown in the drawing. The structure of valve 46 is believed to be known and, by itself, is not my invention.

When balloon 22 is compressed, as indicated by dashed lines 22', fluid is discharged through bore 50 and openings 57, 59 and tube 26 into the compression balloon, distending the compression balloon as indicated by dashed lines 24', 66'. When valve 46 is squeezed between the patient's fingers, sufficient fluid in the distended compression balloon flows back to the reservoir balloon to equilibrate the pressures in both balloons. The compression balloon thus contracts.

In the embodiment of FIG. 6, the inflatable balloon 24 has an entrance connected to tube 26 and has a wall of uniform thickness. Cup 38 is also shown fixedly connected to tube 26 with an upper portion including the entrance to balloon 24 retained inside cup 38. Cup 38 is made of an implantable material which is stiffer or thicker than the wall of balloon 24 and, as later described in more detail, does not deform when balloon 24 is inflated. Cup 38 functions to direct balloon expansion upon inflation so that the greatest expansion occurs along the central axis 64 of tube 26, as indicated by dashed lines 24'.

In the embodiment of FIG. 7, an inflatable balloon 66 is fixedly attached to tube 26. The embodiment of FIG. 7 does not include a discrete retaining member, like cup 38 in FIG. 5B and FIG. 6, but functions in essentially the same manner. Unlike the wall of balloon 24 in FIG. 5B, the wall of balloon 66 varies axially in thickness. As can be seen, the thickest portion of the balloon occurs adjacent its attachment to tube 26. The wall tapers uniformly about the circumference of the balloon, down to minimum thickness at a latitude midway between the end of the balloon attached to tube 26 and the outermost balloon end. Thereafter, balloon 66 is formed of a substantially uniform thickness wall. With balloon 66 so formed, the outermost end of the balloon tends to expand more rapidly in response to balloon inflation than the remainder of the balloon. This causes maximum expansion of balloon 66 along the axis 70 of tube 26, as indicated by a dashed line 66' in FIG. 7.

Turning now to FIG. 8, device 20 is shown after being implanted in a female patient indicated generally at 76. Structure previously identified herein is identified with the same number in FIG. 8. Additional anatomical structure includes the coccyx 78, such comprising the lowermost portion of the spine. Also illustrated are the rectum 80 and vagina 82. In the view of FIG. 8, balloon 24 is shown in a substantially deflated or contracted condition.

In FIG. 9, balloon 24 is illustrated in an inflated condition such that urethra 14 is compressed in an anterior-posterior direction between balloon 24 and the tissue posterior to urethra 14, thereby occluding the urethral lumen as illustrated. A portion of the patient's forefinger 84 is shown in dashed lines compressing the reservoir balloon 22 against the pubis 16. This action forces fluid from reservoir balloon 22 through tube 26 to inflatable balloon 24. The balloon 24 expands axially, preferentially compressing a lengthwise portion of the urethra.

In FIG. 10, device 20 is illustrated implanted in a male patient indicated generally at 86. Included in male patient 86 is a coccyx 88, a rectum 90 and a prostate gland 92, shown in dashed lines, encircling urethra 94. The urethra depends from bladder 96, there being a bladder neck 98 formed between the bladder and urethra 94. Device 20 is mounted via attachment tab 28 to pubis bone 100.

One approach to surgical access for the implantation of the proposed incontinence device is via a standard lower vertical mid-line abdominal or horizontal (Pfannenstiel's) incision, with separation of the rectus muscles to gain access to the retropubic (anterior pelvic) space and to the superior pubic rami.

Reservoir balloon 22 is implanted in a subcutaneous pocket; i.e., overlying the anterior pubic rami and symphysis in an area accessible to the patient for manual actuation (compression of the reservoir balloon). Underlying bone serves as a platform against which the reservoir is compressed.

Inflatable balloon 24 (or 66 in FIG. 7) is connected to reservoir balloon 22 over the superior aspect of the symphysis pubis via tubing 26. Attachment tab 28 is integrated with tube 26 and serves as the only point of fixation of the device to bone or adjacent structures. Balloon 24 is implanted behind the pubic symphysis and above the pubic arch within the retropubic space of the pelvis. Balloon 24 is positioned so that the bladder neck and urethra are compressed by it before the urethra passes through the pelvic diaphragm (not shown) under the pubic arch.

After separation of the rectus muscles via the earlier described standard surgical approaches, only blunt dissection may be necessary to gain access within the retropubic space for implanting the balloon 24 in a fixed relationship with the adjacent superior urethra and bladder neck. No dissection posteriorly or laterally of the urethra and bladder neck is necessary. This greatly simplifies the surgical procedure and avoids the possibility of rectal or vaginal injury. Venous structures in this area, particularly in the mid-line retropubic space, are numerous and large. Little or no dissection of these veins is required. Ligation, if necessary, or compression of these veins by the device 20, should not produce venous stasis since ample collateral veins are present laterally.

Balloons 24, 66 are narrow in the anterior-posterior dimension and wider in the lateral dimension, and oval in cross section to conform to the concavity of the posterior pubic symphysis. This shape stabilizes the compression device between the anterior bladder, bladder neck, and superior urethra posteriorly, and the concave posterior aspect of the pubic symphysis, anteriorly. The bladder as well as the pelvic contents hold the inflatable balloon in position behind the pubic symphysis at or near the mid-line. No additional fixation of device 20 to the posterior pubic bone or pelvic structure is necessary, as the shape of the device allows for stable positioning in this location within the concavity of the pelvis (between the diverging arms of the inferior pubic rami, anteriorly).

An integral and important part of the surgical procedure includes a means to affix the anterior-superior bladder to the posterior rectus fascia above the level of the superior pubic rami. Tube 26 is routed through the mid-line fascia through the incision between the rectus muscle bodies at or near their insertion on the superior aspect of the anterior pubic rami. The fascial incision is closed in standard fashion with interrupted sutures. The most inferior sutures bracket the interconnecting tubing as it exits the pelvis, thus securing fascial tissue around it and preventing herniation. Before fascial closure, a felt matrix or mesh patch 30 (in FIG. 4) of a biologically inert material, such as Dacron, is sewn to the anterior bladder wall over a distance of 2-3 cms. transversely. This, in turn, is sewn via suture 32, to the posterior aspect of the rectus fascia prior to the fascial closure, well above the rectus insertions and device 20. Tissue incorporation into the felt occurs both from the bladder aspect and the fascial aspect, effecting a secure union. This fixes the bladder to anterior structures (abdominal wall) thus stabilizing the bladder and urethra and preventing inferior migration of the bladder with expansion of balloon 24 as might otherwise occur. This concept is an extension of existing surgical principles with regard to stress urinary incontinence correction in the female.

In conjunction with this portion of the surgery, electrodes can be incorporated within the bladder wall, or affixed to it, to record the status of bladder filling via a strain gauge or similar instrument. This sensor, in turn, is linked to a warning device, for the patient who has deficient sensory enervation, or to nursing staff for the incompetent or incapacitated patient, to signal the need for voiding. The potential benefit of such a bladder warning system is great for institutionalized patients who are incapable of normal control (patients with Alzheimer's Disease, etc.). This requires an attentive nursing staff but would be a vast improvement over the incontinence that is often encountered in nursing home and convalescent center environments.

Because of the bladder fixation to be employed in this surgery, and the attendant temporary bladder dysfunction that is frequently seen with similar surgical procedures (e.g., for correction of stress incontinence in the female), it is likely that a temporary form of urinary drainage will be necessary in conjunction with the above described surgery and placement of a device constructed in accordance with the invention. A bladder catheter is placed in the mid-line through the fascial closure at a level higher than the placement of device 20 (again incorporated between fascial interrupted sutures). A Foley catheter or similar retention device is utilized for this purpose and is positioned adjacent the fixation felt 30 to aid in bringing the bladder into close opposition to the anterior abdominal wall via traction on the catheter during the post-operative period. This catheter is removed when voiding function is re-established and the patient is accomplished in the operation in the device and its voiding valve. At that time, the wound should be well-healed and the bladder well-fixed and stabilized anteriorly.

Reservoir balloon volume is carefully monitored at the time of surgery to ensure that adequate bladder emptying is possible when inflatable balloon 24 (in devise 20) is deflated, or at equal pressure with the reservoir. A portion of the reservoir balloon that is accessible from the anterior-superior aspect of this prosthesis component is designed with a self-sealing diaphragm 23 to allow perforation by a non-coring needle introduced through adjacent skin to add or subtract fluid volume.

With reference to FIGS. 8 and 9, after the device is implanted and the patient wishes to close the urethra to prevent bladder voiding, forefinger or fingers 84 is used to compress balloon 22 against pubis 16. When such compression occurs, as shown in FIGS. 6 and 7, fluid in balloon 22 is forced through bore 50. The increased pressure distends membrane 56 away from side 54 of valve body 48 thereby allowing fluid flow from bore 50 through holes 57, 59, and into tube 26 thereby inflating compression balloon 24, 66 and ultimately compressing the urethra between the balloon and the tissue posterior to the urethra. When the patient removes his or her finger(s), back pressure of the fluid in the compression balloon seals membrane 56 against the bore 50, blocking back flow of fluid.

When the patient desires to void his or her bladder, the patient can compress valve body 48 between his or her thumb 72 and forefinger 74 as shown in FIG. 7. Such compression lifts membrane 56 away from side 54 of the valve body thereby permitting flow from compression balloon 24 through tube 26 and holes 57, 59 in membrane 56. The fluid passes through bore 50 and back into reservoir balloon 22, thus allowing the device to resume the configuration shown in FIG. 8. With the balloon no longer inflated, the urethra opens, permitting voiding. After voiding, the patient again compresses the reservoir balloon with his or her forefinger to inflate balloon 24 thereby occluding the urethra lumen, as illustrated in FIG. 9, to prevent incontinence.

Since the inflatable balloon in each embodiment expands primarily along the longitudinal axis of tube 26, increasing expansion is directed in a posterior-inferior direction perpendicular to the pelvic diaphragm (not shown). Compression of the superior urethra results from expansion of the inflatable balloon over a broad surface area. The risk of tissue necrosis is minimal since the urethra is compressed only in the posterior-inferior direction and only with sufficient fluid transfer to effect continence. The compression is directed only upon the anterior wall of the urethra, ultimately compressing the urethra against the sacrum and coccyx posteriorly, with intervening rectum and pelvic contents providing a buffer.

With balloon 24 inflated, the urethra, already elongated and stabilized, is compressed and further lengthened as it is urged posteriorly by the expanding balloon. As the urethra is lengthened, the diameter of the lumen therein decreases, thus requiring less force to occlude the same. The area of compression of the urethra exceeds the anatomic size of the external sphincter in males. The locus of compression is immediately above the urogenital diaphragm (above the external sphincter) in the male. Since the inflatable balloon 24 is secured only by attachment tab 28, it is somewhat mobile. This mobility permits the balloon to be forced into a more inferior position with sudden increased abdominal pressure (such as with coughing, sneezing, etc.) or as directed by the patient (via voluntary Val Salva maneuver) to effect increased urethral compression. This voluntary patient maneuver can be utilized in the competent patient having intact bladder sensation in circumstances such as sudden bladder contraction.

It can be seen that the invention provides a bladder incontinent control method and apparatus which is easily operated and controlled by the patient. The patient controls both the degree of urethral compression, via incremental transfer of fluid from the patient-accessible reservoir balloon, and voiding function. The latter is effected by the patient or nursing personnel by a single manipulation which effects rapid urethral decompression. Another advantage of this invention is the ease of surgical access via standard anterior lower abdominal approaches, avoiding lateral and posterior dissection around the urethra and bladder neck. The concept utilizes urethral compression over a broad area at the highest level feasible, i.e., at the bladder neck and superior urethra. This allows the use of the proposed device in patients who have failed inflatable cuff applications or other surgical treatments at a lower level.

A second approach to implantation uses a laparoscope or trocar in a two-step procedure. In general, the first step or procedure is to place the compression balloon 66 in the retropubic (anterior pelvic) space with the conduit 26 and to elevate and affix the anterior-superior bladder 11 to the posterior rectus fascia of the abdominal wall 33, as shown in FIGS. 12-15. The second step, typically performed as a separate procedure after a urodynamic assessment of the patient's needs, is to implant and interconnect the remaining components 22, 46 of the prosthetic device 20 to form a closed system as shown in FIGS. 16 and 18 and to charge the system with a suitable volume of fluid. Each of these steps, and further details about the urodynamic assessment and its use in determining requisite fluid volume of the system, are described below.

FIG. 11 shows a cystocele and urethrocele condition which has already been described above in connection with FIG. 2. The peritoneal membrane and the abdominal wall are respectively identified by reference numerals 19 and 33.

FIG. 12 shows percutaneous introduction of the occlusion balloon 66 and conduit 26 as a unit via a suitable sheath-type device 100, such as a trocar or preferably a laparoscope. Laparoscopy techniques are currently being employed in a large and increasing number of clinical surgical problems. The majority of these to date have utilized techniques employed within the peritoneal cavity; however, recent advances have brought this technique to the retroperitoneal space. Examples include retroperitoneal pelvic lymphadenectomy, intra aortacaval lymphadenectomy, varicocelectomy, and, in a few cases, nephrectomy, hernia repair and bladder suspension. Access to the pre-vesicle space either subcutaneously or via prior intraperitoneal access using these techniques is both feasible and practical. A similar technique without optical control, namely trocar placement of bladder catheters, has been used for many years. It is possible to introduce the compression balloon prosthesis through a trocar inserted into the pre-vesicle and periurethral space anteriorly. This can be done with a modification of existing trocar designs utilizing indirect visual control via fluoroscopy or bladder ultrasound imaging techniques to accurately place (position) the compression balloon. Direct visual control of this procedure via the use of a laparoscope will be preferable to avoid bleeding, minimize scarring, and increase accuracy.

The sheath-type device 100 can be inserted directly into the peritoneal space through the abdominal wall 33 via the umbilicus. Preferably, device 100 is inserted through the abdominal wall via a small incision 102 through the midline fascia anteriorly of the peritoneal cavity at a lower level as shown in FIG. 12. Then, the forward end of device 100 is guided inferiorly through the patient's preperitoneal space and retropubic space into the space of Retzius anteriorly adjacent the bladder neck 12. Once this is done, the compression balloon 66 is introduced into the space of Retzius through device 100 in a collapsed condition with conduit 26 attached.

Next, referring to FIG. 13, the compression balloon is inflated to help retain it in the space of Retzius and the sheath device 100 is withdrawn through incision 102. Then, the trailing, transcutaneous end of conduit 26 is pushed upward subcutaneously from incision 102 to a second incision 104 sufficiently remote from incision 102 to isolate incision 104 from the pathway through which compression balloon 66 was introduced to minimize prospects for any infection that might occur around incision 104 reaching the prevesicle space. The first incision 102 is then closed completely and the second incision 104 is closed around the protruding trailing end of conduit 26 with a subcutaneous fixation barrier. Recent developments of both materials and surgical technique have allowed long-standing safe placement and maintenance of externally-accessible catheters for the delivery of drugs, such as chemotherapeutic agents in advanced cancer treatment. Infection rates with these devices, currently less than 1% over many months of use, have shown steady improvement with the advances that continue to evolve. These techniques and materials are used in this method for the initial placement and a temporary "test phase" of the compression balloon component of the artificial sphincter, as described below.

FIG. 14 shows the further step of introducing a balloon-type retraction device, such as a Foley catheter which includes a retention balloon 106 and drainage tube 107, suprapubically into the anterior bladder. This is done by inserting a trocar 108 through an incision 110 and deviating laterally from the midline to avoid conduit 26, preferably by several centimeters so as to isolate the two tracts from one another to minimize risk of transfer of infection. The Foley cather is used to retract the anterior bladder into contact with the abdominal wall, elevating the bladder and elongating the urethra, as described above and shown in FIG. 15. A third trocar 112 is inserted through the abdominal wall via incision 114 and a suitable fabric (e.g. Dacron described above in connection with FIG. 4.

Referring to FIG. 17, two patches 30A and 30B, spaced laterally about the Foley catheter, can be used to increase the security of affixation of the anterior bladder to the abdominal wall. As another alternative, two incisions can be made initially at the level of incision 102, laterally spaced for use in positioning patches 30A and 30B. One of these incisions can be used for initial implantation of the compression balloon to help isolate conduits 26 and 107 from one another. If necessary to center or adjust the final position of the compression balloon, the second incision could be used for introducing a laparoscope or other positioning device to effect that purpose. Otherwise, the other incision can serve as incision 104.

Referring back to FIG. 15, the retention balloon is then inflated and retracted anteriorly to draw the anterior bladder wall into contact with the abdominal wall with the adjacent patch(es) sandwiched between the abdominal and bladder walls. Trocar 108 is then withdrawn and the incision 110 is closed around drainage tube 107 (i.e., the Foley catheter). Trocar 112 is also withdrawn and incision 114 is closed. The patches are preferably affixed solely by ingrowth of tissues from the adjoining bladder and abdominal walls but may also be secured with sutures 32 or reinforced by insertion of staples to anchor the patches to the abdominal muscle.

Referring to FIGS. 16 and 18, implantation of the integrated (final) prosthesis 20, 20A is completed after the secure placement and testing of the compression balloon with definition of pressure/volume relationships and effectiveness. A reservoir/valve assembly 22, 46 is placed in any convenient accessible subcutaneous location to be connected to the compression balloon component. This step requires only minor surgery accomplished under local anesthesia.

The system 20, 20A is charged with a sufficient volume of fluid to effect a desired level of continence as determined by preceding ambulatory testing. In general, the system should contain sufficient fluid that, by compressing the reservoir, enough fluid can be transferred into the compression balloon to distend it sufficiently to occlude the lumen of the urethra. At the same time, the compression balloon should have, when distended, sufficient tension to expel a volume of the fluid backward into the reservoir when valve 46 is opened sufficient to permit the patient's urethra to pass urine. This means that the fluid pressure in the compression balloon, when distended, must exceed the simultaneous fluid pressure in the reservoir, when the reservoir is not being manually compressed. To meet these needs, the reservoir should be sized to contain a larger volume of fluid under low pressure than is contained by the compression balloon even when distended. The total volume of fluid in the system should not be such that the reservoir must be distended under high tension when the valve is opened in order to receive enough fluid from the compression balloon to permit voiding. The specific sizes and moduli of elasticity, and the requisite fluid volumes, will need to be determined experimentally in individual patient testing, using a conventional manometer or pressure tranducer available in urodynamic test instruments. These parameters are likely to vary from patient to patient due to the fact that the compression balloon is subject to internal pressures which will vary with patient's size and weight and different anatomy, and transitory conditions such as bladder fullness, coughs and sneezes, and changes of pressure related to posture and/or activity.

The site chosen for the implantation of the reservoir component of the system can be varied. A position overlying the anterior surface of the pubic symphysis, as shown in FIG. 16, will be advantageous for elderly persons who are not sexually active. A different site (any adjacent soft tissue area, typically the scrotum in the male or labia majora in the female), can be chosen for the sexually active patient. FIG. 18 shows placement of the reservoir/valve assembly 22, 46 at a subcutaneous location on the patient's abdomen or side. Assembly 22, 46 can also be positioned laterally under the patient's superior lateral ileum.

After the first procedure and an opportunity to try out the effectiveness of the compression balloon 66, the patient will have the option of proceeding to completion with implantation of the reservoir/valve assembly 22, 46 (second phase) or abandoning the proposed prosthesis in favor of other forms of surgery or non-surgical control means. In the case of the female with severe stress urinary incontinence (type III classification), a posterior approach utilizing a conventional "sling procedure" could be elected. The anterior site of the above balloon placement utilized in this proposal will not interfere with surgery directed to the posterior urethra as in the sling procedure. In some instances, it may be possible to utilize the prior art circumferential cuff artificial sphincter following removal of the anterior compression balloon since the site of implantation of the cuff can be either directed elsewhere or at the same level (urethral locus). In the latter case, the anterior dissection will already have been accomplished, thus simplifying the surgery somewhat.

Having illustrated and described the principles of my invention in two alternative embodiments, in both males and females, it should be appreciated that additions and modifications may be made without departing from such principles. I claim all variations and modifications within the spirit and scope of the following claims.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 is a simplified diagram showing a lateral sectional view of a normal bladder and pubis of a human female in standing position.

FIG. 2 is a view similar to FIG. 1 showing a cystocele and urethrocele condition.

FIG. 3 illustrates a conventional surgical correction of the condition shown in FIG. 2.

FIG. 4 is a view similar to FIG. 1 showing a simplified diagram illustrating implementation of the present invention to correct urinary incontinence in either male or female.

FIG. 5 is a more detailed lateral view of the device shown implanted in FIG. 4.

FIG. 5A is a frontal elevation view taken along line 5A--5A in FIG. 5.

FIG. 5B is a longitudinal section view taken along line 5B--5B in FIG. 5.

FIG. 5C is a cross-sectional view taken along line 5C--5C in FIG. 5B.

FIG. 6 is a sectional view taken along lines 6--6 in FIG. 5A showing interior details and operation of the first embodiment with the reservoir being inflated and compression balloon deflated in solid-lines and the reservoir deflated and compression balloon inflated in dashed lines.

FIG. 7 is a view similar to FIG. 6 of a second embodiment of the invention, showing operation of the releasable check valve to equilibrate the reservoir and compression balloon to permit voiding.

FIG. 8 is a more detailed female anatomic diagram similar to the view of FIG. 4 showing a device constructed in accordance with the invention in deflated condition to permit voiding.

FIG. 9 is a view like FIG. 8 showing the compression balloon in a filled condition for occluding the urethra.

FIG. 10 is a male anatomic diagram similar to the view of FIG. 8, showing the compression balloon deflated in solid lines and inflated in dashed lines.

FIG. 11 is a view similar to FIG. 2 showing an urethrocele condition prior to surgery in accordance with the method of the present invention as illustrated in FIGS. 12-18 below.

FIGS. 12, 13 and 14 are views similar to FIG. 11 showing a first procedure in the method of the present invention.

FIG. 15 is a view similar to FIG. 14 showing post-operative conditions in a time interval after the first procedure, during which urodynamic assessment is conducted in accordance with the present invention.

FIG. 16 is a view similar to FIG. 15 showing post-operative conditions after the second procedure to complete implantation of the remaining components of the artificial sphincter.

FIG. 17 is cross section taken along lines 17--17 in FIG. 15 showing the lateral location of adherence patches.

FIG. 18 is a view similar to FIG. 16 showing an alternative placement of the remaining components of the artificial sphincter in the second procedure.